PMA P960009S443

Device: Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S443
Product code: MHY
Decision date: 2022-11-22
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Separation of a manufacturing process, Bond Pad Array (EPA) Lid Removal, as a standalone process for better tracking at internal supplier Medtronic Tempe Campus (MTC); and the addition of a videoscope manufacturing equipment for improved process controls.

Current openFDA PMA Record#

Device: Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S443
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2022-11-22
Decision code: OK30
Date received: 2022-11-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Separation of a manufacturing process, Bond Pad Array (EPA) Lid Removal, as a standalone process for better tracking at internal supplier Medtronic Tempe Campus (MTC); and the addition of a videoscope manufacturing equipment for improved process controls.